What is riociguat?

Riociguat is used to treat chronic thromboembolic pulmonary hypertension (CTEPH) in people who cannot be treated with surgery, or in people who have undergone surgery but still have symptoms. Riociguat can treat certain symptoms of CTEPH and can improve your ability to exercise.

Riociguat is used to treat pulmonary arterial hypertension (PAH). Riociguat can improve your ability to exercise and help prevent PAH from getting worse.

Riociguat is available to women only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication.

Riociguat may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking riociguat?

You should not use riociguat if you are allergic to it, or if:

you are pregnant or might become pregnant during treatment; or

you have PAH related to a condition called idiopathic interstitial pneumonias (PH-IIP).

Some medicines can interact with riociguat and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

a nitrate drug for chest pain or heart problems (amyl nitrite, nitroglycerin, and others); or

other medicines to treat PAH (Adcirca or Revatio).

Do not take riociguat within 24 hours before or after taking sildenafil (Revatio, Viagra), or within 24 hours before or 48 hours after taking tadalafil (Adcirca, Cialis).

To make sure riociguat is safe for you, tell your doctor if you have:

heart disease, blood circulation problems;

low blood pressure;

a condition called pulmonary veno-occlusive disease (PVOD);

a recent history of coughing up blood or bleeding from your lung;

liver disease;

kidney disease (or if you are on dialysis);

if you smoke; or

if you are dehydrated.

Do not use riociguat if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your treatment ends. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.

You will need to have a negative pregnancy test before starting this treatment. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine. Do not have unprotected sex.

Even if you are not planning a pregnancy, you are considered able to become pregnant if:

you have entered puberty (even if you have not yet started having periods);

you have never had a hysterectomy or had your ovaries removed; or

you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).

While taking riociguat, girls and women who are able to get pregnant must use highly effective birth control, or two methods together.

A tubal ligation alone is an effective birth control method.

An intrauterine device (IUD) or birth control implant alone are also effective birth control methods.

If you use birth control pills, injections, skin patches, or vaginal rings, you must use a back-up barrier form of birth control, such as a condom or diaphragm or cervical cap. Always use a spermicide gel or insert together with a barrier form of birth control.

If you use only a barrier method, you must use a second barrier method as a back-up. For example, use a diaphragm or cervical cap in addition to a condom, plus a spermicide gel or insert.

If your sexual partner has had a vasectomy, you must still use a second method of birth control--either a barrier method or a hormonal form (birth control pills, injections, skin patch, or vaginal ring).

Riociguat comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are the parent or caregiver of a female child taking this medication, talk to the child's doctor once you notice any signs of puberty (breast development or pubic hair), even if menstrual periods have not yet begun.

It is not known whether riociguat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take riociguat?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Riociguat is usually taken 3 times per day. Space your doses 6 to 8 hours apart.

You may take riociguat with or without food.

You may need frequent medical tests to help your doctor determine how long to treat you with riociguat.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor if you miss your doses for 3 days in a row or longer.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking riociguat?

Do not have unprotected sex while taking riociguat. You must use birth control to prevent pregnancy during treatment and for at least 30 days after you stop taking this medicine.

Riociguat can cause dizziness and may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking an antacid within 1 hour before or after you take riociguat. Some antacids can make it harder for your body to absorb riociguat.

Smoking can make riociguat less effective. Tell your doctor if you start or stop smoking while you are taking this medicine. Your dose needs may need to be changed

What are the possible side effects of riociguat?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using riociguat and call your doctor at once if you have:

a light-headed feeling, like you might pass out;

abnormal vaginal bleeding, or any other unusual bleeding;

vomiting or coughing up bright red blood, or vomit that looks like coffee grounds;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect riociguat?

Other drugs may interact with riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about riociguat.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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